In the health and wellness industry, the use of nutraceuticals is currently at an all-time high. In this growing and competative industry, it is more important now than ever before to meet customer demands and maximize cost efficiency – while also staying in compliance with governing regulatory bodies such as the FDA.
21 CFR Part 11 Compliance
Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11) is a piece of legislation passed by the FDA which sets specific guidelines for electronic record keeping for drug manufacturers.
The manufacture of a nutraceutical might be subject to this regulation if it is classified as a drug by the FDA.
Some of the most important parts of this legislation are its guidelines for electronic signatures. Traditional pharmaceutical manufacturing requires that certain critical steps must be verified with a second signature from a supervisor on the batch record.
In accordance with FDA legislation, these second signatures are no longer necessary. This is because data taken directly from the scale itself is used as an electronic signature / verification of the step.
Our Recipe Manager module allows you to easily create of recipes for even the most complex formulations.
With clear, step-by-step process instructions, you can also be assured that your operators will follow the recipe exactly.
Forward And Reverse Traceability
With Valdata, you can quickly and easily forward and reverse trace just about every aspect of your operation from raw materials to finished goods. This also includes batch records, equipment used, personnel involved, testing performed, and much more.
Our software was designed to meet the stringent requirements of the FDA to make you audit-ready.
Comprehensive QA/QC Management
Perform testing and approval of incoming materials and manufactured goods within our software.
Nutritional Analysis and Labeling
Our software can even calculate a nutritional analysis of your formulation based on the raw materials used.